Study confirms that Avastin significantly increases chance of living without disease progression in metastatic breast cancer

Data from pivotal phase III AVADO study presented at ASCO for the first time

Avastin (bevacizumab), significantly improves the time patients with metastatic breast cancer live without their disease getting worse (“progression-free survival”) when combined with a commonly used chemotherapy called docetaxel (Taxotere), compared with docetaxel alone. These findings were presented for the first time today at the American Society of Clinical Oncology (ASCO) meeting in Chicago. This is the second large phase III trial that met its primary endpoint by showing that Avastin provides a significant improvement in progression-free survival in HER 2 negative metastatic breast cancer patients. This follows the recently published landmark E2100 study (Avastin plus paclitaxel versus paclitaxel alone).

The results of the phase III “Avastin and Docetaxel” (“AVADO”, BO17708) study showed that the combination of Avastin and docetaxel resulted in:

Up to a 64% increase in a patient’s chance of being alive without disease progression compared to docetaxel alone.
Up to two thirds of patients (63%) experiencing major shrinkage of their tumor, which is unprecedented.
No new safety signals related to Avastin. Furthermore, Avastin did not have a major impact on the known toxicity profile of docetaxel.
Principal investigator for AVADO, Dr David Miles, medical oncologist, Mount Vernon Hospital, UK said: “This is the second large phase III study to confirm that Avastin extends the time in which patients live without disease progression in combination with a widely used chemotherapy agent. Importantly this study has confirmed that Avastin can be used with taxane- based chemotherapy to provide a meaningful benefit for patients with metastatic breast cancer.”
Two doses of Avastin were investigated in the study (7.5 and 15 mg/kg given every three weeks). The AVADO study was not powered to detect a difference in efficacy between the two doses, however, there was a numerical advantage for efficacy parameters in favor of the 15 mg/kg dose arm. These results, and those of the other landmark study (E2100), support use of this dose (5mg/kg/week). Overall survival data are still immature at present and are expected in 2009.

“The positive results of the AVADO study are encouraging news for patients suffering from metastatic breast cancer and confirm Avastin’s benefits as a treatment against this devastating disease” said William M. Burns, CEO Pharmaceuticals Division of Roche. “With our Avastin development program – the biggest trial program in oncology ever – we will continue to develop the best possible treatment approaches to increase survival and improve quality of life of cancer patients.”

This second large phase III trial follows the recently published E2100 study. Results from E2100 formed the basis of European Commission approval and FDA accelerated approval of Avastin in combination with the widely used chemotherapy paclitaxel for the first-line treatment of metastatic (HER-2 negative) breast cancer in March 2007 and February 2008 respectively. Study E2100 showed that the addition of Avastin to paclitaxel doubled patients’ chance of being alive without disease progression compared to paclitaxel alone.

Each year more than one million women are diagnosed with breast cancer leading to over 400,000 deaths globally.